FDA.reportPublic FDA data

BAOT

Primary DI
06973133310756
Brand
BAOT
Company
BAOT Biological Technology Co., Ltd.
Model
JC S-1C 3g
Device description
Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.
Published
2020-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182350000Dental CeramicBaot Biological Technology Co., Ltd.2019-05-22EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973133310756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973133310756069731333107566973133310756

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560453518
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936536149873BAOT®ZCG B0M2 50g2026-07-04
06936536143772BAOT®Zirconia Ceramic,Dentine,B0M32026-04-20
06973133314235BAOT®JC Opaque B1 50g2024-08-21
06973133314280BAOT®JC Opaque A3 50g2024-08-20
06973133313726BAOT®OP B0M2 5g2023-07-29
06973133312583BAOTJC OP A2 50g2023-06-30
06973133312392BAOTJC OP B3M3 15g2022-07-14
06973133312408BAOTJC OD D3 15g2022-07-14
06973133312415BAOTZCG 5M3 15g2022-07-14
06973133312422BAOTZCG 5M2 15g2022-07-14
06973133312439BAOTZCG 5M1 15g2022-07-14
06973133312446BAOTZCG 4R2.5 15g2022-07-14
06973133312453BAOTZCG 4R1.5 15g2022-07-14
06973133312460BAOTZCG 4M3 15g2022-07-14
06973133312477BAOTZCG 4M2 15g2022-07-14
06973133312484BAOTZCG 4L2.5 15g2022-07-14
06973133312491BAOTZCG 3R2.5 15g2022-07-14
06973133312507BAOTZCG 3M3 15g2022-07-14
06973133312514BAOTZCG 3M2 15g2022-07-14
06973133312521BAOTZCG 3M1 15g2022-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106160Prettau 5 106H16ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106170Prettau 5 106H17ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106180Prettau 5 106H18ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106190Prettau 5 106H19ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106200Prettau 5 106H20ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106210Prettau 5 106H21ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106220Prettau 5 106H22ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106230Prettau 5 106H23ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106240Prettau 5 106H24ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106250Prettau 5 106H25ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106260Prettau 5 106H26ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106270Prettau 5 106H27ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106280Prettau 5 106H28ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106290Prettau 5 106H29ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106300Prettau 5 106H30ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106310Prettau 5 106H31ZIRKONZAHN SRLEIH2026-09-18